Combined therapy with dutasteride and tadalafil vs dutasteride or tadalafil monotherapy in benign prostatic hyperplasia: a randomised phase III trial.
What's New
A fixed-dose combination of dutasteride and tadalafil was associated with significantly greater symptom improvement than either drug alone in men with BPH.
Detailed Summary
A phase III randomized trial of 619 men with BPH found that a fixed-dose combination of dutasteride 0.5 mg/tadalafil 5 mg was associated with a 9.49-point reduction in IPSS at 48 weeks, compared to 4.40 for dutasteride alone and 4.24 for tadalafil alone (P < 0.001 for both). Adverse events occurred in 32.88% of the combination group vs 21.20% and 26.48% in the monotherapy groups.
Study Population
667 men with benign prostatic hyperplasia, stratified by baseline symptom severity
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